Prosthesis, Hip, Hemi-, Femoral, Metal
FDA adverse event reports and recall history for prosthesis, hip, hemi-, femoral, metal (product code KWL), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,668
- Deaths
- 4
- Injuries
- 2,018
- Malfunctions
- 607
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-07-16Open, ClassifiedEmployee error
UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
- 2024-07-16Open, ClassifiedEmployee error
UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
- 2024-07-16Open, ClassifiedEmployee error
UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
- 2018-02-12TerminatedMixed-up of materials/components
CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).
- 2018-02-12TerminatedMixed-up of materials/components
CORAIL HIGH OFFSET STEM Collarless SIZE 14
Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).
- 2009-09-14TerminatedNonconforming Material/Component
Corin Unipolar Adapter Sleeve, For use with Corin Unipolar CoCr Heads; Not for use w/ceramic heads; not for use w/ Stainless Steel implants. Stryker Orthopaedics. Indicated for use in partial hip replacement procedures for patients suffering from pain and disability due to a variety of related bone disease.
The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. As a precaution and due to the potential impact on the mechanical properties of the products, St
- 2009-07-22TerminatedProcess control
Omniflex-HA Hip Stem W/C Taper. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- 2008-03-20TerminatedProcess control
Stryker Orthopaedics, UHR Universal Bipolar Component; 26 x 42 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- 2008-03-20TerminatedProcess control
Stryker Orthopaedics UHR Universal Bipolar Component; 26 x 44 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- 2008-03-20TerminatedProcess control
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 44 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
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